Lamotrigine Bioequivalence Study to Compare Dispersible Tables With Compressed Tablets in China

Inclusion criteria

• According to medical history and clinical examination, healthy and non-smoking male subjects
• Between 18 and 45 years of age, inclusive.
• Body weight >=50 kg and BMI 19-24 kg/m2, inclusive.
• Male subjects with female partners of child-bearing potential must agree to use one of the following contraceptive methods after the first dose of study treatment and until the follow up visit:

• Condom plus partner use of a highly effective contraceptive such as occlusive cap (diaphragm or cervical/vault cap) plus spermicidal agent (foam/gel/film/cream/suppository), oral contraceptive, injectable progesterone, implant of etonogestrel or levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, or intrauterine device. OR,
• Abstinence, defined as sexual inactivity consistent with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
• Good compliance with research policies, procedures and restrictions.
• Can read and understand the informed consent. Informed consent should be obtained prior to admission to the study.
• No abnormality revealed by the laboratory tests, or any slight abnormality judged by the investigator to have no clinical significance.
• Aspartate aminotransferase (AST), ALT, alkaline phosphatase and bilirubin=<1.5 x upper limit of normal (ULN).
• Normal systolic (90-140 mmHg) and diastolic (<90 mmHg) blood pressure at screening, and normal pulse (supine).
• A normal 12-lead ECG at pre-study screening.
• Single or average QT duration corrected for heart rate by Bazett's formula (QTcB) or by Fridericia's formula (QTcF) <450 msec; or QTc <480 msec in subjects with bundle branch block.
• Liver serum virological and human immunodeficiency virus tests are negative

Exclusion criteria

• Any clinically relevant abnormality identified on the screening history and physical or laboratory examination significant cardiovascular, neurological, psychiatric, haematological or renal abnormalities.
• Definite or suspected personal history or family history of adverse reactions or hypersensitivity to the study drug or to drugs with a similar chemical structure.
• Participation in a clinical trial within the 30 days before the start of the study.
• The subject has received prescribed medication or over-the-counter (OTC) medicine including herbal medicines within 14 days before the first dosing day. The use of lubricant with spermicide or contraceptive barrier devices and other contraceptives is permitted.
• History of any clinically significant illness within 4 weeks before the study.
• History of any clinically significant physical or organic abnormalities.
• Abnormalities of 12-lead ECG which the investigators think increase the risk of participation in the study.
• History of liver dysfunction such as jaundice, or hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCAb) positive regardless of ALT level or ALT greater than or equal to 2-times ULN. Subjects with Gilbert's syndrome will be excluded from the study.
• Positive pre-study screening result for hepatitis B antigen, hepatitis C antibodies or HIV-1 or HIV-2 antibody.
• Subject whose HLA-B*1502 is positive will be exclude from the study.
• Abuse of alcohol, defined as an average weekly intake of greater than 21 units or an average daily intake of greater than three units. One unit is equivalent to half a pint (~ 240 mL) of beer, one (25 mL) measure of spirits or one glass (125 mL) of wine.
• Positive pre-study drug/alcohol screen.
• History of obvious active haematological disorder or significant blood loss in the past 3 months.
• Subject donated blood within a 56-day period or donated plasma within 1 week prior the study.
• Subject is mentally or legally incapacitated.
• Any other reason at the Investigators' discretion